A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04540705
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Axitinib — DRUG
    Specified dose on specified days
  • Cabozantinib — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.

Key Dates

Start date
Sep 11, 2020
Status verified
Feb 2024
Primary completion
Jan 18, 2024
Completion
Jan 18, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A (Part 1): Nivolumab + Axitinib
  • Experimental: Part 1B (Part 1): Nivolumab + Cabozantinib

Primary Outcome Measure

Incidence of adverse events (AEs) by severity (Part 1) [ Time Frame: Up to 2.5 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Local Institution - 0005SpringdaleArkansas72762-
Local InstitutionLouisvilleKentucky40202-
Local Institution - 0001St LouisMissouri63110-
Local Institution - 0009New YorkNew York10065-
Local InstitutionPortlandOregon97213-
Local InstitutionNashvilleTennessee37232-
Local Institution - 0014HoustonTexas77030-3721-
Local Institution - 0007SeattleWashington98109-

Find similar trials in Springdale, AR

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Local Institution - 0005· Springdale, ARLocal Institution· Louisville, KYLocal Institution - 0001· St Louis, MOLocal Institution - 0009· New York, NYLocal Institution· Portland, ORLocal Institution· Nashville, TN

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